Asiaticoside extracted from Centella asiatica is a commercially available analytical reference standard material with companies such as, for example, Yick-Vic Company having attributed Asiaticoaside purity of 92.8% by HPLC, Tauto Biotech Company having attributed Asiaticoaside purity around 97% by HPLC, and Baoji herbest Biotech Company having Asiaticoaside assay more than 98%. However, these products are specifically adapted to be used as a reference standard for research purposes in the research laboratories and not found to be an extract of plant centella asiatica. These asiaticoside products are not commercially viable to be used as a pharmaceutical composition.
The processes adapted for preparation of asiaticoside from centella asiatica claim purity ranging between 50%-97% in the prior art. For example, US Publication No. 2008/0194499 teaches pharmaceutical pentacyclic terpenoid glycosides that include asiaticoside composition ranging between 15-50%. Also, US Publication No. 2006/0177516 discloses a terpenic mixture having asiaticoside composition around 40%. Moreover, U.S. Pat. No. 6,417,349 provides a centella asiatica extract having range 4:6 to 6:4 to constitute 97% or more of the extract. In addition, Chinese Patent No. CN 1520824 discloses an extraction and separation method for asiaticoside that has purity 92.8%. However, none of the prior art has attempted exclusive extraction of highly pure asiaticoside from centella asiatica. 
The traditional use of Centella Asiatica or Asiaticoside includes promoting wound healing, treatment of skin diseases, skin disorders and chronic inflammatory diseases. For example, Chinese patent no. CN 101129393 discloses the use of asiaticoside liquid in wound healing. In addition, US Publication No. 2009/0060985 teaches uses of centella asiatica urban extract as a drug substance for treatment of skin disorders. There are few attempts seen in the art wherein the asiaticoside or centella asiatica is employed for non-traditional uses. For example, US Publication No. 2008/0194499 teaches the use of terpenoid glycosides, preferably asiaticoside and madecassoside optionally along with excipients, for management of depression. Also, US Publication No. 2006/0177516 provides a food supplement that shows uses of Asiaticoside for treatment of anemia conditions.
However, the use of asiaticoside or centella asiatica for management of diseases related to gastrointestinal tract such as inflammatory bowel disease and helicobacter pylori is relatively unknown. There are few attempts seen in the art wherein the asiaticoside is used for treatment of liver diseases. For example, Chinese patent nos. CN1439376 and CN 1520824 disclose the use of asiaticoside for preventing and treating fibrosis of liver. In addition, US Publication No. 2004/0097463 discloses the use of asiaticoside for treatment of cancer associated with liver, colon and pancreas. In addition, Cheng et al., 2004, (“The healing effects of Centella extract and asiaticoside on acetic acid induced gastric ulcers in rats”, Life Sciences, vol. 74, pp. 2237-2249) discusses the healing effects of Centella asiatica water extract on acetic acid induced gastric ulcers in rats. Also, Cheng et al., 2000, (“Effects of Centella asiatica on ethanol induced gastric mucosal lesions in rats”, Life Sciences, vol. 67, pp. 2647-2653) teaches preventive effect of water extract of Centella asiatica on ex-vivo experiments of ethanol induced gastric mucosal lesions. However, the gastric ulcers stated in the art are restricted to chemical or drug induced ulceration models. Moreover, these models specifically create a lesion by local application of an irritant (acetic acid) in the stomach which may not necessarily address the diseases of the colon such as inflammatory bowel diseases. Moreover, the asiaticoside products in the art claim for treatment of ulcers, but fail to specify the use of asiaticoside for prevention of ulcers.
Inflammatory Bowel Disease is characterized by intractable, chronic inflammatory conditions such as Ulcerative Colitis and Crohn's Disease which display distressing symptoms of abdominal pain, diarrhea, vomiting, hematochezia (blood in stools), reduced appetite, weight loss, fever and various associated complications such as anal fissures, fistulas, perirectal abscess, hemorrhoids, for example. Ulcerative Colitis and Crohn's Disease are usually assessed by disease activity index, which includes stool frequency, presence of blood in stool, endoscopic appearance, and physician's global assessment. Persistence of above conditions leads to chronic inflammation and subsequently becomes the causative factors for development of colonic cancers. The existing methods of treatment for inflammatory bowel diseases include the reduction of abdominal pain, diarrhea, fatigue, anemia, nutrient deficiencies, mucosal inflammation, extra intestinal manifestations, hospitalizations, operations, and complications, such as abscesses, fistulae, infections, and malignancy.
The treatment of inflammatory bowel diseases consists of oral administration of sulfasalazine, immunosupressants and corticosteroids. Normally, Sulfasalazine is a preferred first line treatment for mild to moderate Ulcerative Colitis and Crohn's Disease. However, the side effects such as drug intolerance, impaired folic acid absorption, renal adverse effects make Sulfasalazine undesirable for inflammatory bowel disease treatment. Further, the availability of Sulfasalazine at the colon is limited due to its absorption in the stomach and subsequent excretion in the urine. Ulcerative Colitis and Crohn's Disease, in acute conditions, require treatment with corticosteroids but these drugs cannot prevent remission. Long term use of corticosteroids is associated with skin thinning, susceptibility to laceration, weight gain, increase in blood pressure, diabetes and related adverse conditions. Immunosuppressants are effective in long term treatment of Ulcerative Colitis and Crohn's Disease. These drugs also have significant adverse reactions such as bone marrow suppression, lymphomas (in renal transplant patients), skin cancer and pancreatitis. The inflammatory bowel disease require surgery in severe cases, such as bowel resection, stricture plasty or a temporary or permanent colostomy or ileostomy which involves use of general anesthesia and complications of post operative recovery. Ulceration of gastrointestinal tract by mucosal damage is an associated complication of inflammatory bowel disease. The chronic nature of inflammatory bowel disease and associated inflammatory diseases require long term management therapy. Current methods of treatment of inflammatory bowel disease have limitations of adverse side-effects on sustained treatment and high risk of remission of the disease.
The inflammations that are induced by pathogenic bacteria such as helicobacter pylori help facilitate to aggravate the symptoms of inflammatory bowel diseases. Moreover, the environmental factors such as stress, food and alcohol consumption amplify the activity of helicobacter pylori. The World Health Organization (WHO) has categorized helicobacter pylori as group-I carcinogen for promoting gastric carcinoma. The helicobacter pylori infection triggers chronic inflammatory reaction that damages epithelial cell followed by induction of gastric atrophy that eventually leads to gastric carcinoma. The treatment of gastric carcinoma or gastric cancer has highly fatal treatment options such as, for example, surgical removal of cancerous tissue by gastrectomy, removal of part/total stomach, chemotherapy, radiation and chemo radiation. However, these treatments have substantially high side-effects that lead poor quality of life to the patients. Also, these treatments do no assure complete recovery as there is a high probability of recurrence of the carcinoma. Timely diagnosis and treatment for eradication of helicobacter pylori from infected gastric mucosa may greatly reduce the risk of gastric carcinoma. A user may appreciate an effective means for eradication of helicobacter pylori infection, which can indirectly help in prevention of gastric carcinoma induced by helicobacter pylori infection.
A commercially viable method for extraction of asiaticoside from centella asiatica is needed that has a very high purity to be effectively used as a pharmaceutical composition. An asiaticoside composition is further needed that provides a kinder and gentler method for effective long-term management of inflammatory bowel disease along with helicobacter pylori. An asiaticoside composition is further needed that prevents gastric diseases and colon cancers that are induced due to inflammatory bowel diseases. An asiaticoside composition is further needed for effective eradication of the helicobacter pylori infection that prevents a gastric carcinoma.